At TBD Pharmatech, we offer comprehensive analytical quality control services, providing robust support for your pharmaceutical drug substance development and manufacturing needs. Our inhouse analytical laboratories specialize in developing and validating precise analytical methods, supporting your regulatory submissions, ensuring compliance, and delivering reliable, timely data. Whether you require targeted analytical support or end-to-end QC solutions, our analytical experts ensure your project’s quality, efficacy, and regulatory success.
Analytical QC services
Service overview
Analytical QC services
Stand-alone Analytical Services
We provide the following specialized analytical services as standalone offerings, tailored to meet specific client requirements:
- Analytical Method Development and Validation including HPLC-UV, HPLC-CAD, GC-FID, GC-HS, water content, titration
- Development and Synthesis of Reference Materials and Impurities
- Trace Analysis (e.g., residual solvents, elemental impurities, heavy metals)
- Analytical Support for Process Validation and Scale-up
- Forced Degradation and Stability Studies (ICH guidelines)
- Impurity Identification, Isolation, and Quantification
- Genotoxic/Mutagenic Impurity Evaluation
- Microbiological and Endotoxin Testing
- Powder X-ray Diffraction (PXRD) Analysis
- Particle Size Distribution (PSD) Analysis
- Chiral Analysis (HPLC) and Optical Rotation Measurements
- Water Content Determination (Karl Fischer)
- Photostability and Thermal Stability Evaluations
- Residual Solvent and Volatile Organic Compound (VOC) Analysis
- Counter-ion Identification and Quantification
- Melting Point and Physical Property Analysis
- Comprehensive Regulatory Analytical Documentation
Have a project in mind? Let’s discuss!
API CDMO that delivers a tailored range of fine chemical development and manufacturing solutions to pharmaceutical and biotech companies.